THE INFLUENCE OF COMPENDIAL CELLS DESIGN AND
EXPERIMENTAL SETUP ON THE IN-VITRO SIMILARITY OF
KETOCONAZOLE TOPICAL CREAMS
DRAGOȘ FLORIAN CIOLAN1, ALINA MÎNEA2*, ADRIAN A. ANDRIEȘ3, ANCA CECILIA
NICOARĂ2, FLAVIAN ȘTEFAN RĂDULESCU3, DALIA SIMONA MIRON4
“Carol Davila” University of Medicine and Pharmacy Bucharest, Faculty of Pharmacy, 6 Traian Vuia Street, 020956,
Bucharest, Romania
1Department of Pharmaceutical Chemistry
2Department of Pharmaceutical Technology and Biopharmaceutics
3Department of Drug Industry and Pharmaceutical Biotechnologies
4Department of Pharmaceutical Physics and Informatics
*corresponding author: minea.alina88@yahoo.com
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Abstract:
Two cream dosage forms containing 2% ketoconazole with significant similarity of their qualitative composition were
comparatively analyzed by compendial tests using vertical diffusion cells and immersion adaption for the standard
dissolution equipment. The mean in-vitro release profiles displayed marked differences between reference listed drug and the
generic formulation, independent on the design of the cell and implemented operational parameters. These results
corresponded to a marked non-similarity in terms of microstructure, as revealed by the hysteresis loop test. Considering that
both topical semisolid formulations are approved by the regulatory authorities, probably based on clinical endpoint studies,
the in-vitro data can be regarded as proofs of the overly discriminatory character of the methodology.

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